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The InVision 1.5 Surgical Theatre is indicated for use as a magnetic device (MRDD) that produces transverse, sagittal, coronal and oblique cross sectional images, spectroscopic images and that displays the internal structure and/or function of the head, body or extremities. Other physical parameters derived from the images and/or spectra may also be produced. Depending on the region of interest, contrast agents may be used. These images and/or spectra and the physical parameters derived from the images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis. The InVision 1.5 Surgical Theatre may also be used for imaging during intraoperative and interventional procedures when performed with MR safe devices or MR conditional devices approved for use with the MR scanner. The InVision 1.5 Surgical Theatre may also be used for imaging in a multi-room suite.

The proposed InVision™ 1.5 Surgical Theatre is a traditional Magnetic Resonance Imaging (MRI) scanner that is suspended on an overhead rail system. It is designed to operate inside a Radio Frequency (RF) shielded room to facilitate intraoperative and multi-room use. The InVision 1.5 Surgical Theatre uses a scanner, the Siemens MAGNETOM Sola (K203443, reference device), to produce images of the internal structures of the head as well as the whole body. The Siemens 1.5T MAGNETOM Sola MRI scanner is an actively shielded magnet with a magnetic field strength of 1.5 Tesla. The InVision 1.5 Surgical Theatre provides surgeons with access to magnetic resonance (MR) images while in the surgical field without changing the surgical/clinical workflow. When images are requested in the operating room (OR), the magnet is moved from the diagnostic room (DR) to the OR on a pair of overhead rails while the patient remains stationary during the procedure. Imaging is performed and once complete the magnet is moved out of the OR to the DR. The magnet can be moved in and out of the surgical field multiple times, as required, throughout the course of the surgical procedure. When the Siemens MAGNETOM Sola MRI scanner is in the DR, the OR may be used as a standard OR, utilizing standard surgical instruments and equipment during surgery. When not required in the OR, the scanner is available for use in the DR as a standard diagnostic MRI.

The IMRIS iMRI 3T V is indicated for use as a magnetic resonance diagnostic device (MRDD) that produces transverse, sagittal, coronal and oblique cross sectional images, spectroscopic images and/or spectra, and that displays the internal structure and/or function of the head, body or extremities. Other physical parameters derived from the images and/or spectra may also be produced. Depending on the region of interest, contrast agents may be used. These images and/or spectra and the physical parameters derived from the inages and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis. The IMRIS iMRI 3T V system may also be used for imaging during intra-operative and interventional procedures when performed with MR safe devices or MR conditional devices approved for use with the MR scanner. The IMRIS iMRI 3T V MRI systems may also be used for imaging in a multi-room suite.

The IMRIS iMRI 3T V is a traditional MRI unit that has been suspended on an overhead rail system, and is designed to operate inside an RF shielded room to facilitate intra-operative and multi-room use. The magnet is normally situated in a Diagnostic Room (DR) until imaging is requested. The system retains all standard diagnostic features of an MRI system in the DR. The DR is separated from the intra-operative Operating Room (OR) by sliding doors that are part of the facility structure. The IMRIS iMRI 3T V is a tool for radiologists and surgeons, used to acquire images for diagnostic, intraoperative, or interventional procedures. For OR purposes, high-resolution images can be obtained immediately prior to surgical incision, intraoperatively, and after wound closure. The IMRIS iMRI 3T V is based on the IMRIS iMRI 3T S cleared under 510(k) K133692 and the Siemens MAGNETOM Vida MRI system cleared under 510(k) K192924. The major components of the IMRIS iMRI 3T V system are: the Siemens MAGNETOM Vida MRI system with minor modifications, IMRIS Magnet Mover System, RF coils, Application platform, OR Table Assembly, Head fixation device, IMRISeye, and Horseshoe headrest.